FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
31753–31776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2016
icotec Pedicle System
K151977 · NKB
Icotec AG
Orthopedic · 270d
Cleared Apr 12, 2016
HealthChek Network Health Station
K152107 · DXN
Healthchek Network, LLC
Cardiovascular · 258d
Cleared Apr 12, 2016
All Poly Tibial Component
K152430 · JWH
United Orthopedic Corporation
Orthopedic · 230d
Cleared Apr 12, 2016
Cytosponge Cell Collection Device
K152794 · EOX
Covidien, LLC
Ear, Nose, Throat · 197d
Cleared Apr 12, 2016
Superbium
K153229 · GEX
Bios S.R.L.
General & Plastic Surgery · 158d
Cleared Apr 12, 2016
TelioCAD Multi
K153753 · EBG
Ivoclar Vivadent, Inc.
Dental · 105d
Cleared Apr 12, 2016
EndoSize
K160376 · LLZ
Therenva Sas
Radiology · 62d
Cleared Apr 12, 2016
Arthrex iBalance BiCompartmental Arthroplasty System
K160461 · KRR
Arthrex, Inc.
Orthopedic · 53d
Cleared Apr 12, 2016
ARIES System
K160517 · OOI
Luminex Corporation
Microbiology · 48d
Cleared Apr 11, 2016
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA...
K152013 · LSW
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Apr 11, 2016
Winco Model S550 Stretchair
K152056 · INK
Winco Manufacturing, LLC
Physical Medicine · 262d
Cleared Apr 11, 2016
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
K152454 · KWD
Arthrosurface, Inc.
Orthopedic · 227d
Cleared Apr 11, 2016
LifeGlobal Micro Tips
K152581 · MQH
Life Global Group, LLC
Obstetrics & Gynecology · 214d
Cleared Apr 11, 2016
TREFOIL System
K152836 · DZE
Nobel Biocare AB
Dental · 195d
Cleared Apr 11, 2016
BioMonitor 2-AF, BioMonitor 2-S
K152995 · MXD
Biotronik, Inc.
Cardiovascular · 181d
Cleared Apr 11, 2016
Noris Medical MBI Dental Implant System
K153043 · DZE
Noris Medical , Ltd.
Dental · 175d
Cleared Apr 11, 2016
Hoffmann LRF (Limb Reconstruction Frame) System
K153377 · KTT
Stryker GmbH
Orthopedic · 140d
Cleared Apr 11, 2016
Map-it Diagnostic Mapping Catheters
K160390 · DRF
Access Point Technologies Ep, Inc.
Cardiovascular · 60d
Cleared Apr 08, 2016
LifeCare PCA Infusion System
K143612 · MEA
Hospira, Inc.
General Hospital · 476d
Cleared Apr 08, 2016
Noris Medical Zygomatic Dental Implant System
K151909 · DZE
Noris Medical , Ltd.
Dental · 270d
Cleared Apr 08, 2016
MagView BIOMAGNETOMETER SYSTEM
K152184 · OLY
Tristan Technologies, Inc.
Neurology · 247d
Cleared Apr 08, 2016
Nihon Kohden Afib Detection Program QP-039P
K152305 · DSI
Nihon Kohden Corporation
Cardiovascular · 238d
Cleared Apr 08, 2016
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
K153063 · GEI
Teleflexmedical, Inc.
General & Plastic Surgery · 169d
Cleared Apr 08, 2016
Nephros S100
K153084 · NHV
Nephros, Inc.
Gastroenterology & Urology · 165d